Elderly Patients with Acute Myeloid Leukemia Are Not All the Same: Results of the Prospective DSIL AML96 Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1840-1840
Author(s):  
Markus Andreas Schaich ◽  
Walter E. Aulitzky ◽  
Heinrich Bodenstein ◽  
Martin Bornhaeuser ◽  
Thomas Illmer ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Prognostic Factors ◽  
High Risk ◽  
Elderly Patients ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Low Risk ◽  
Severe Toxicity ◽  
Elderly Aml ◽  
Acute Myeloid

Abstract The majority of patients with acute myeloid leukemia (AML) are older than 60 years at diagnosis. However, treatment results for these elderly patients are still unsatisfactory. This is thought to be due to a more aggressive disease, preexisting co-morbidities or a decreased tolerance for intensive treatment approaches. As for younger patients there is growing evidence that elderly AML patients may be divided into prognostic subgroups. So far data on prognostic factors in this group of patients are still sketchy. Between February 1996 and March 2005 a total of 827 elderly AML patients with a median age of 67 (61–87) years were treated within the prospective AML96 trial of the German Study Initiative Leukemia (DSIL). 643 patients had de novo and 184 patients secondary disease. All patients were scheduled to receive a double induction therapy with Daunorubicin and Ara-C (DA3+7). The consolidation therapy consisted of one course of m-Amsacrine and intermediate-dose (10g/m2) Ara-C. 265 (32%) patients reached CR criteria after double induction therapy. Forty-two patients (5%) had only a PR, 307(37%) displayed refractory disease, 126(15%) died during induction therapy and 77(10%) received only one course of induction therapy due to severe toxicity. Out of the 265 patients in CR 120 (45%) patients received the consolidation course. The strongest independent prognostic factors for achieving a CR were less than 10% blasts in the day 15 bone marrow, the presence of a NPM mutation or a low-risk karyotype (p<0.0001 each). The 3-year overall (OS) and relapse-free survival (RFS) rates were 18% for all patients and 17% for all patients in CR, respectively. In the multivariate analysis the strongest prognostic factors for survival were age, LDH and cytogenetics (p<0.0001 each). Using these three parameters a prognostic model for survival was established. Patients older than 70 years with intermediate- or high-risk cytogenetics and a high LDH level at diagnosis (n=213) had a 3-year OS of only 9%, whereas patients with low-risk cytogenetics or patients with intermediate-risk cytogenetics, younger than 70 years and a low LDH level (n=237) had a 3-year OS of 32%. All other patients (n=377) had an intermediate 3-year OS of 15% (p<0.0001). In conclusion, elderly AML patients can be stratified into prognostic groups. AML patients older than 70 years with high LDH levels and intermediate- or high-risk cytogenetics at diagnosis do not profit from conventional chemotherapy.

Induction Treatment In Elderly Patients with Acute Myeloid Leukemia (AML): Randomized Comparison of Intermediate-Dose Cytarabine Plus Mitoxantrone (IMA) Versus Standard-Dose Cytarabine Plus Daunorubicin (DA) In 492 AML Patients >60 Years – Results From the SAL 60plus Trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 334-334 ◽  
Author(s):  
Christoph Röllig ◽  
Michael Kramer ◽  
Mathias Hanel ◽  
Regina Herbst ◽  
Norbert Schmitz ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Elderly Patients ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Induction Treatment ◽  
Term Survival ◽  
Elderly Aml ◽  
To Receive ◽  
Acute Myeloid ◽  
Intermediate Dose

Abstract Abstract 334 Background: The majority of patients diagnosed with Acute Myeloid Leukemia (AML) are older than 60 years. Although intensive induction chemotherapy is still the standard practice and a prerequisite for long-term survival, elderly patients have a higher risk of treatment related morbidity and lower remission rates than younger AML patients. An optimized induction treatment would combine high complete remission (CR) rates with tolerable toxicity. The combination of intermediate-dose cytarabine plus mitoxantrone (IMA) has recently been reported to result in high CR rates (73.5%) with acceptable toxicity in 86 elderly AML patients (Niederwieser et al., Blood 2002, abstr. 1337). We present the results of a randomized-controlled trial (RCT) comparing efficacy and tolerability of IMA with the standard 7+3 induction regimen consisting of daunorubicin plus cytarabine (DA). Patients and Method: In the 60plus trial of the Study Alliance Leukemia (SAL, former DSIL), AML patients >60 years considered medically fit for chemotherapy were randomized to receive either intermediate-dose cytarabine (1000 mg/m2 BID days 1,3,5,7) plus mitoxantrone (10 mg/m2 days 1–3) (IMA) or standard induction therapy with cytarabine (100 mg/m2 continuously days 1–7) plus daunorubicin (45 mg/m2 days 3–5) (DA). All patients who achieved a CR received cytarabine based consolidation treatment (2+5/MAMAC). Primary endpoint was the CR rate with an expected difference of 15% based on the results of the study named above. Secondary endpoints were the incidence of serious adverse events (SAEs), time to relapse (TTR), disease-free survival (DFS), and overall survival (OS). Result: A total of 492 patients with a median age of 69 years (range, 61–84) were enrolled between 2003 and 2009 by 29 German centers. 248 were randomized to receive IMA and 244 to receive DA. Patient characteristics were similar in the two treatment arms. In the intention-to-treat analysis, the CR rate was 59.3% (95% CI, 53.1–65.2) in the IMA arm and 51.2% (95%CI, 45.0–57.4) in the DA arm (p= 0.085). Mortality during the first 2 months after the start of study treatment was 18.1% and 18.4% in the IMA and the DA arm, respectively. Forty-five SAEs and grade-4 non hematological toxicities in 43 patients (19%) were reported in the IMA arm, while there were 57 SAEs in 52 patients in the DA arm (23%; p=0.1866). After a median follow-up time of 25.7 months (2.1 years), the median TTR is 10.3 months for IMA and 11.1 months for DA (p=0.328), the median DFS is 10.2 versus 11.7 months (p=0.11) and the median OS is 9.7 versus 10.8 months for IMA versus DA (p=0.945). This results in a 1-year OS of 43.6% in the IMA arm and 46.9% in the DA arm. Conclusion: Our current results show an equal efficacy and toxicity of both induction regimens. The trend for a higher CR rate after IMA does not translate into a survival advantage. Thus, our study indicates that elderly AML patients do not benefit from a dose escalation of cytarabine in induction therapy. Disclosures: No relevant conflicts of interest to declare.

Addition of Lomustine to Idarubicin and Cytarabine Improves the Outcome of Elderly Patients With De Novo Acute Myeloid Leukemia: A Report From the GOELAMS

2010 ◽  
Vol 28 (18) ◽  
pp. 3028-3034 ◽  
Author(s):  
Arnaud Pigneux ◽  
Jean-Luc Harousseau ◽  
Francis Witz ◽  
Mathieu Sauvezie ◽  
Marie-Christine Bene ◽  
...  
Keyword(s):  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Elderly Patients ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
De Novo ◽  
Group I ◽  
Acute Myeloid

Purpose No significant improvement in treatment outcome has been seen in elderly patients with acute myeloid leukemia (AML) over the past 20 years. This retrospective analysis investigated the prognostic factors for complete remission (CR) and survival in older patients with AML. Patients and Methods The study involved 847 patients older than 60 years enrolled onto three trials carried out in France between 1995 and 2005. Induction therapy consisted of idarubicin (8 mg/m2, days 1 through 5) and cytarabine (100 mg/m2, days 1 through 7; group I, 339 patients) or the same drugs plus lomustine (200 mg/m2 orally on day 1; group II, 508 patients). Consolidation therapy consisted of anthracycline and cytarabine courses at lower doses, preceded or not by a first course of intermediate-dose cytarabine. Results The rate of CR was significantly higher in patients in group II compared with group I (68% v 58%; P = .002). The rate of toxic death was similar in the two groups. In multivariate analysis, two prognostic factors were linked to CR: nonadverse cytogenetic (P < .003) and addition of lomustine to induction chemotherapy (P = .002). Median overall survival was significantly improved in patients treated with lomustine (median and SE, 12.7 ± 2.2 months v 8.7 ± 2.7 months; P = .004). In multivariate analysis, five prognostic factors positively affected overall survival: addition of lomustine (P = .002), age ≤ 69 years (P < .001), Eastern Cooperative Oncology Group performance status lower than 2 (P = .002), French-American-British subgroup 1/2 (P = .02), and nonadverse cytogenetic (P < .001). Conclusion Lomustine improves the rate of CR and survival in elderly patients with de novo AML when added to standard induction therapy.

Induction Therapy with Idarubicin and Etoposide Combined with Sequential or Concurrent Azacitidine In Patients with High-Risk Acute Myeloid Leukemia: Pilot-Phase of the AMLSG 12-09 Study

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2184-2184
Author(s):  
Frank G. Rücker ◽  
Stephan Stilgenbauer ◽  
Martin Bommer ◽  
Daniela Späth ◽  
Silja Mack ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
High Risk ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Research Funding ◽  
Single Agent ◽  
Severe Toxicity ◽  
Overall Response ◽  
History Of ◽  
Acute Myeloid

Abstract Abstract 2184 Background: Treatment outcome in patients with cytogenetically and/or molecularly defined high-risk acute myeloid leukemia (AML) is dismal with low complete remission (CR) rates after intensive induction therapy and 5-year overall survival of about 25% in patients 60 years and younger and far below 5% in patients above the age of 60 years. In younger patients, allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched related or unrelated donors results in significantly better clinical outcome especially if patients are transplanted early in first CR (Schlenk et al., J. Clin. Oncol. 2010, in press). Azacitidine is a demethylating agent showing promising results as a single agent in AML patients with bone marrow blast counts between 20 and 30%. Therefore, the randomized AMLSG 12-09 trial will evaluate the combination of idarubicin/etoposide chemotherapy combined with azacitidine instead of cytarabine as compared to induction with idarubicin/etoposide/cytarabine (ICE) in an attempt to increase CR rates in these high-risk patients. Aim: To evaluate feasibility of the investigational induction therapy with idarubicin and etoposide in combination with sequentially or concurrently administered subcutaneous (sc) azacitidine. Methods: Patients were treated according to the investigational treatment schedules of the AMLSG 12-09 protocol. Patients received idarubicin 12 mg/sqm on days 1, 3 and 5 and etoposide 100 mg/sqm on days 1, 2 and 3 (patients above the age of 65 years received idarubicin 12 mg/sqm and etoposide 100 mg/sqm only on days 1 and 3, respectively). Azacitidine 100 mg/sqm sc was added on days -5 to -1 in 7 patients (schedule A), days 1 to 5 in 6 patients (schedule B), and days 4 to 8 in 5 patients (schedule C). Results: 18 patients have been treated (13 males and 5 females). Median age was 62.5 years (range, 28–76). The cytogenetic and molecular risk profile of the 18 AML was as follows: Eight AML had MDS-related cytogenetic changes (WHO 2008) including five exhibiting a complex karyotype and two had 3q abnormalities; three AML had balanced t(v;11q23), and six exhibited a normal karyotype together with triple negative genotype (NPM1-wt, FLT3-wt and CEBPA-wt). In one case, there were no metaphases available, however molecularly NPM1-wt, FLT3-wt, CEBPA-wt, no core binding factor AML, no t(15;17) and or t(9;11) were present. Median WBC was 4.6/nl (range, 0–6-75/nl). Overall response to induction therapy was CR n=7, partial remission (PR) n=3, refractory disease (RD) n=7 and one patient died during induction therapy (ED). Moreover, two patients with RD achieved CR after additional cycles of single agent azacitidine treatment. Overall response rates (CR and PR) according to treatment schedule were 43% (3/7), 67% (4/6) and 80% (4/5) for schedules A, B and C, respectively. Most common azacitidine-related toxicity was local reactions at injection site not exceeding CTC-grade 2. As expected, fever in neutropenia was the most common severe toxicity (83%). In addition, one patient with history of epilepsy had seizures during induction therapy and one patient with history of Crohn‘s disease had mucositis CTC-grade 3. Allo-HSCT has been performed in three patients and is planned in five. After a median time of 7.5 months, 16 of 18 patients are alive. Conclusion: Azacitidine administered sc can be given safely either sequentially or concurrently in combination with idarubicine/etoposide induction chemotherapy. Response rate of this high-risk population appears promising and the toxicity profile was favorable. The question which schedule is the most effective will be addressed in the randomized AMLSG trial (NCT01180322) Disclosures: Stilgenbauer: Amgen: Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Boehringer-Ingelheim: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Genzyme: Consultancy, Honoraria, Research Funding; GSK: Consultancy, Honoraria, Research Funding; Mundipharma: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding; Sanofi Aventis: Research Funding. Döhner: Pfizer: Research Funding. Schlenk: Celgene, Pfizer, Novartis, Cephalon, Amgen: Research Funding.

Comparison of Outcome and Prognosis of 248 Elderly Patients with Acute Myeloid Leukemia Treated with Standard-Dose or Low-Intensity Induction Therapy

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2540-2540
Author(s):  
Jianda Hu ◽  
Yi Chen ◽  
Xiaoyun Zheng ◽  
Zhihong Zheng ◽  
Ting Yang ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Prognostic Factors ◽  
Elderly Patients ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Standard Dose ◽  
Performance Status ◽  
Low Intensity ◽  
Induction Cycle ◽  
Acute Myeloid

Abstract Acute myeloid leukemia (AML) is a disease of older adults, with a median onset age at about 65-70 years. The treatment outcome of AML appears to be poorer with the age increasing, in part due to the poor performance status, concomitant end-organ dysfunction, higher incidence of unfavorable cytogenetic findings, frequent involvement of a more immature leukemic precursor clone, multidrug resistance mediated by MDR1/P-glycoprotein, and the presence of antecedent hematopoietic disorders. Treatment of elderly patients with AML remains highly challenging and controversial. The overall survival rates at 5-year of ≥ 60 years old AML patients are still less than 20% by now. At present, standard-dose induction chemotherapy using a cytarabine plus idarubicin(IA regimen) or daunorubicin (DA regimen) was considered by most to be the most effective upfront AML induction therapy. However, there are still quite a number of elderly patients could not tolerate because of poor performance status and complications. Therefore, low-intensity chemotherapy, including CAG regimen, which combine low-dose cytarabine, aclacinomycin and granulocyte colony-stimulating factor(G-CSF), was used for those were not appropriate for receiving standard-dose chemotherapy. Here we retrospectively analyzed the outcome and prognosis of elderly patients with AML treated with standard-dose or low-intensity induction therapy. 248 elderly patients with acute myeloid leukemia(AML) who received standard-dose or low-intensity induction therapy were enrolled in this retrospective clinical study, 186 patients in standard-dose group with 144 in IA and 42 in DA, 62 cases in low-intensityCAG group. The maininclusion criteria included age ≥ 60 years old, ECOG performance status ≤ 2, without severe complication of heart, liver, kidney or other important organ. The patients received standard-dose or low-intensity induction regimen according to their performance status and patient preference. 144 patients received IA regimen(idarubicin 10mg/m2/d ,d1-3; cytarabine 100mg/m2, q12h, d1-5 or 7), 42 patients received DA regimen(daunorubicin 60mg/m2/d, d1-3; cytarabine 100mg/m2 q12h, d1-5 or 7), and 62 patients received CAG regimen (cytarabine 10mg/m2 q12h, d1-14; aclacinomycin 20mg qd, d1-4; G-CSF 200ug/m2 qd, d0-14, or until bone marrow recover). The median survival time was 9.2 months. 1-year , 3-year and 5-year overall survival(OS) were 42.2%, 18.9% and 13.5%, respectively. After first induction cycle, complete remission(CR) rate was 49.3% in IA group, 35.7% in DA group and 32.3% in CAG group (P = 0.046). The median OS for IA, DA and CAG group were 10.0 months, 9.7months and 7.5 months, respectively. The early mortality of induction therapy and recurrence rate of three regimens showed no difference. IA could improve the long term survival compared to CAG and DA, with 3-year OS: 23.5%,15.9% and 8.3%, respectively; 5-year OS: 19.4%, 6.3%, and 0, respectively (P<0.01). The 67.0% patients relapsed within 24 months, with median relapse time of 8.4 months, 14.6 months and 8.3 months for IA, DA and CAG regimen, respectively. Moreover, Kaplan-Meier analysis showed that 7 parameters were adverse prognostic factors for OS, including age ≥ 70 years old, poor ECOG performance status, unfavorable cytogenetics, non-remission after first induction cycle, white blood cell (WBC) counts ≥ 50×10^9/L, percentage of bone marrow (BM) blast ≥ 80% and higher lactic dehydrogenase (LDH) . Multivariable analysis identified non-remission after first induction cycle (HR = 6.141, 95%CI: 3.585-10.52, P = 0.000) and LDH ≥ 490 IU/L(HR = 1.001, 95%CI: 1.000-1.001, P = 0.000) as independent significantly prognostic factors for OS. In conclusion, Our present data showed that standard-dose IA regimen could improve CR rate and prolong the survival time compared to low-intensity CAG regimen, and CAG regimen still has a certain therapeutic effect for those unfit for intensive chemotherapy. Recurrence is still a serious problem for those who do not receive Allo-HSCT for consolidation after CR. All prognostic factors should be considered before induction therapy to make sure the patients receive the best individualized treatment. Disclosures No relevant conflicts of interest to declare.

Standard Induction Followed by Attenuated Consolidation Therapy in Elderly Patients with Acute Myeloid Leukemia.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4602-4602
Author(s):  
Je-Hwan Lee ◽  
Seong-Jun Choi ◽  
Jung-Hee Lee ◽  
Miee Seol ◽  
Keun Hee Kim ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Febrile Neutropenia ◽  
Elderly Patients ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Consolidation Therapy ◽  
Elderly Aml ◽  
Grade 3 ◽  
Acute Myeloid ◽  
Fatal Complications

Abstract Compared to younger patients with acute myeloid leukemia (AML), elderly patients are associated with poorer prognosis and only a few survive long-term. Although several randomized trials demonstrate that elderly patients benefit from full-dose application of cytarabine plus anthracyclines rather than less intensive chemotherapy for induction therapy, optimal post-remission therapy remains to be determined. We performed a prospective phase II multicenter trial of standard induction therapy (7+3 of cytarabine plus daunorubicin) followed by 2 cycles of attenuated consolidation therapy (5+1 of cytarabine plus daunorubicin) for elderly AML patients excluding M3. This study was designed to reduce fatal complications by intensive post-remission therapy, benefits of which have not been evidenced in elderly patients. Induction therapy consisted of cytarabine (200 mg/m2/d x 7) and daunorubicin (45 mg/m2/d x 3). If interim bone marrow examination, which was done at 14 days after the start of induction therapy, showed persistent leukemia, the second attempt of induction therapy was tried with the same doses of cytarabine for 5 days and daunorubicin for 2 days. The patients who attained complete remission (CR) by induction therapy received 2 cycles of attenuated dose consolidation therapy (cytarabine 200 mg/m2/d x 5 plus daunorubicin 45 mg/m2/d x 1). Forty-one patients, 25 males and 16 females, were enrolled into the study between Jan 2002 and Dec 2004. Median age was 66 years (range, 60–78 years). Thirty-seven patients received the planned dose of induction therapy and 4 did not complete it due to intolerance in 3 or tumor lysis syndrome in 1. CR was attained in 16 patients after a first attempt of induction therapy. A second attempt of induction therapy was administered to 16 patients, 8 of whom attained CR. Overall, 24 (58.5%; 95% CI, 43.5–73.6%) of 41 enrolled patients achieved CR at a median of 34 days (range, 21–86 days). In the 17 patients who did not achieve CR, the cause of treatment failure was resistant leukemia in 15, complications of aplasia in 1, and indeterminate in 1. Of 24 CR patients, 17 completed all 2 cycles of consolidation therapy, 3 received 1 cycle, and 4 did not receive consolidation therapy. During induction therapy, most common non-hematologic toxicities (≥ grade 3) were febrile neutropenia (83%) and metabolic abnormalities (44%). During consolidation therapy, non-hematologic toxicities (≥ grade 3) were infrequent except febrile neutropenia (45% for the first consolidation and 41% for the second consolidation). There were no fatal complications during consolidation therapy. After a median follow-up duration of 566 days (range, 63–1190 days) among surviving patients, 27 died and actuarial 3-year overall survival was 17.0%. No patient died in remission. Fifteen of 24 CR patients relapsed and actuarial 3-year disease-free survival was 22.5%. Our study suggests that attenuated consolidation does not compromise the outcomes of elderly AML patients, compared to the results from previous reports using more intensive consolidation therapy.

Risk-Adapted Therapy in Younger Adults with Acute Myeloid Leukemia: Results of the AMLHD98A Trial of the AMLSG.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 14-14 ◽  
Author(s):  
Richard F. Schlenk ◽  
Konstanze Dohner ◽  
Hans Pralle ◽  
Katharina Götze ◽  
Michael Pfreundschuh ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
High Risk ◽  
Induction Therapy ◽  
Myeloid Leukemia ◽  
Normal Karyotype ◽  
Low Risk ◽  
High Dose ◽  
Intermediate Risk ◽  
Consolidation Therapy ◽  
Acute Myeloid

Abstract Objective: To evaluate outcome of younger adult patients with acute myeloid leukemia (AML) allocated to different treatment strategies according to the risk factors “karyotype” and “response to first induction cycle”. Methods: Between 1998 and 2004, 871 patients (age 16–60 yrs) were enrolled. 77% of pts had de novo AML, 16% s-AML, and 7% t-AML. Risk stratification was based on cytogenetics and response to first induction therapy: i) low-risk: t(8;21); ii) intermediate-risk: normal karyotype, inv(16), t(11q23) or other rare aberrations; iii) high-risk: abn(3q), −5/5q-, −7/7q-, abn(12p), abn(17p) or complex karyotype and/or all pts having refractory disease (RD) after the 1st or not achieving complete remission (CR) after the 2nd induction. All pts received first induction with ICE (idarubicin, cytarabine, etoposide) followed by a second cycle ICE in case of CR/PR; pts with RD after first induction were assigned to high-dose cytarabine based salvage therapy. Pts achieving CR after response-adapted induction received first consolidation therapy with HAM. Second consolidation therapy was stratified according to the risk definition: i) low-risk pts were assigned to a second course of HAM; ii) intermediate-risk pts with an MRD were assigned to a HLA-matched related donor (MRD) stem cell transplantation (SCT), whereas the remaining pts were either randomized between autologous SCT and a second course of HAM in case of normal karyotype or assigned to autologous SCT if cytogenetic aberrations were present; iii) all high-risk pts were assigned to allogeneic SCT from a MRD or unrelated donor (MUD). Results: Response after response-adapted double induction therapy was as follows: CR 70%, RD 18%, death 12%. In 69 pts risk assessment could not be performed due to unsuccessful cytogenetics; 701 (91%) were assigned to a specific risk: i) high-risk n=255 (36%); ii) intermediate-risk: 408 (58%) pts, comprising 254 pts with normal karyotype and 154 with aberrations; iii) low-risk: 38 pts. (5%) with t(8;21). The median follow-up time was 47 months. Overall survival (OS) for the whole study population at 4 years was 40% (95%-CI 37-42%). All 38 low-risk pts received intensive chemotherapy translating in an OS of 75% (95%-CI 61%-92%). Intention to treat-analysis for intermediate-risk patients exhibiting a normal karyotype revealed a relapse free survival (RFS) of 63%, 38% and 46% for patients assigned to MRD-SCT, autologous SCT and HAM, respectively (p=0.01). However, this difference in RFS did not translate into a difference (p=0.36) in OS due to effective salvage treatment, i.e. mainly MUD-SCT. Within the intermediate-risk group defined by cytogenetic abnormalities no difference in RFS (p=0.16) and OS (p=0.61) was evident between the intended MRD-SCT and autologous SCT. High-risk: 93 pts received MUD-SCT, 57 MRD-SCT, and 93 no allogeneic SCT, resulting in a feasibility of 58% and an OS of 28%, 29% and 5%, respectively (p&lt;0.0001). Conclusions: In this prospective study, allogeneic SCT from MRD or MUD improved outcome of patients with high-risk features. In addition, pts with normal karyotype had a significant better RFS after allogeneic SCT.

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